Regulatory Affairs

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From drug discovery through commercialization, there are a number of steps that are carefully regulated and regulated by global health authorities. Organizations employ experienced professionals for Regulatory Affairs to ensure compliance throughout the process and to oversee the procedures across the product life cycle. In fact, the expert team serves as a vital link between the firm and global health authorities, tracking all of the product’s key regulations and launch criteria. Given their dedicated focus and approach to innovation and drug safety, few many organisations have the privilege of enjoying these teams in-house at the present.

Maven operates as a bridge between organisations and key regulators such as the US FDA, Health Canada, and European Health Authorities at times as a specialised worldwide Regulatory Affairs partner. Maven is a world leader in regulatory affairs services and a pioneer in providing strategic multidisciplinary regulatory affairs consulting services. Maven provides a complete range of regulatory affairs services for product development, registration, and commercialization.

Maven’s global regulatory affairs services allow Life Sciences, Consumer Pharma, and Bio-Med companies understand and properly manage the demanding complexity of Regulatory requirements in order to successfully launch products in new markets and enhance market value.

MAVEN Expertise

  • Submission Forecast and Planning
  • Submission Document Management and Tracking
  • Regulatory Content Management
  • Change Control Management
  • Label Change Tracking
  • Integrated Regulatory Information
  • Regulatory Intelligence
  • Reporting and Analytics